Complementary Medicines
Using the Food-Medicine Interface Tool for Dietary Supplements
Background
The guidance tool was initially developed to assist in identifying whether a product that sat at the food-medicine interface would be most appropriately regulated under food legislation or under therapeutic product legislation. It was based on the assumption that there would be only two possible categories for such products - food (regulated under Food legislation) and medicine (regulated under Therapeutic Product legislation).
Separation of Products Currently Regulated as Dietary Supplements
The Dietary Supplements Regulations 1985 currently regulate a number of products in various presentations. Following proposed amendment of these regulations, therapeutic-type dietary supplements would continue to be regulated under the amended Dietary Supplements Regulations administered by Medsafe, whereas food-type dietary supplements would be regulated as supplemented foods under food legislation administered by NZFSA.
The guidance tool can be useful in identifying whether a dietary supplement would fall into the food-type dietary supplement category or the therapeutic-type dietary supplement category.
In general, if the answer to questions 1 and 2 is "yes" the product is likely to be a therapeutic-type dietary supplement. Question 3 is not relevant in dividing dietary supplements into the food-type and therapeutic-type categories, since therapeutic claims are not permitted for dietary supplements.
Whilst the tool can be used to separate products into different categories and indicate how they would be regulated, it cannot be used to determine whether a particular product will be compliant with the relevant legislation.
Worked Examples
Example 1
A mineral supplement presented in capsules with an instruction to take 2 capsules per day. The label states that the product is a convenient source of essential minerals that are often lacking in modern diets.
Using the tool, the answer to question 1 and 2 is "yes". This product would therefore be considered to be a therapeutic-type dietary supplement.
Example 2
A tablet of compressed milk powder plus vitamins that is intended to be prepared by dissolving one tablet in a glass of water to make a nutritious drink for those too busy to eat healthily during the day.
While the product is in the form of a tablet, it is not administered in this form and is instead used to make a drink. This product would therefore be considered to be a food-type dietary supplement.